RecruitingNCT06500728

Visual Involvement in Giant Cell Arteritis

Sponsor

ASST Fatebenefratelli Sacco

Enrollment

762 participants

Start Date

Jun 27, 2024

Study Type

OBSERVATIONAL

Conditions

Giant Cell Arteritis Visual Impairment

Summary

This observational study aims to enhance the description of the different ways Giant Cell Arteritis (GCA) affects vision. The latest technology and knowledge are used to improve how we diagnose and predict patient outcomes. GCA is the most frequent vasculitis, an inflammation of vessels, in older adults. It involves large and medium-sized arteries and causes ischemic alterations such as stroke and blindness, through damage of extracranial arteries. The primary objective is to compare the frequency of the various ocular findings between the main alterations of arteritic and non-arteritic aetiology, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) Vs. Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION) or Central Retinal Artery Occlusion (CRAO) from GCA Vs. from other causes, through a comprehensive clinical and instrumental evaluation.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

For GCA group:
Patients older than 18 years with clinically suspected or confirmed gigantocellular arteritis.
Newly found visual involvement with suspected or confirmed correlation with vasculitis.
Ability to express valid consent to study enrolment.
For control group:
Patients older than 18 years with the ability to express valid consent to study enrolment.
Newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology.

Exclusion Criteria5

Pre-existing ophthalmological pathologies that may modify best visual acuity and/or alter ophthalmological semeiotics.
Concomitant active viral, bacterial, fungal and parasitic infections, including active or latent tuberculosis treated for less than 4 weeks and HIV, hepatitis C virus (HCV)
/hepatitis B virus (HBV) infections, involving the eyes and orbital cavities.
Concomitant systemic inflammations not attributable to GCA (inflammatory diseases in treatment-free remission are not excluded).
Any other condition judged by the investigators to be a contraindication of eligibility

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Interventions

DIAGNOSTIC_TESTFluorescein and Indocyanine green Angiography

The ophthalmologist frequently recommends fluorescein (FAG) and indocyanine green angiography (ICGA) at baseline (T0) to evaluate retinal and choroidal vascularisation. They can be repeated also after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4) or 26 ± 2 weeks (T5).

DIAGNOSTIC_TESTHigh-resolution Optical Coherence Tomography

The ophthalmologist often suggests performing HR-OCT initially (T0) to assess the width of the macula and optic nerve with potential signs of ischemic lesions in these areas. This assessment can also be repeated after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

DIAGNOSTIC_TESTAngio-Optical Coherence Tomography

The ophthalmologist often suggests OCT-A at the beginning (T0) to assess the retinal and choroidal vascularization. These tests can also be done after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).